A Phase 3, Double-masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle In Subjects With Dry Eye Disease (STRIDE 3)
Phase of Trial: Phase III
Latest Information Update: 07 Nov 2019
Price : $35 *
At a glance
- Drugs Loteprednol etabonate (Primary)
- Indications Dry eyes
- Focus Registrational; Therapeutic Use
- Acronyms STRIDE 3
- Sponsors Kala Pharmaceuticals
- 07 Nov 2019 According to a Kala Pharmaceuticals media release, the company is targeting topline data from this trial in the first quarter of 2020 and resubmission of the NDA in the first half of 2020.
- 08 Aug 2019 According to a Kala Pharmaceuticals media release, the company is targeting topline data from this study by the end of 2019 and resubmission of the NDA during the first half of 2020. The Company believes this resubmission would be subject to a six-month review under the Prescription Drug User Fee Act.
- 08 Aug 2019 According to a Kala Pharmaceuticals media release, the company received a complete response letter (CRL) from the U.S. (FDA) regarding the Companys new drug application (NDA) for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.The FDA indicated that efficacy data from an additional clinical trial will be needed to support a resubmission.